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Significant Reduction In Life-Threatening Illness Anticipated As New Pneumococcal Vaccine Enters The Market

Date:

April 21, 2000

Source:

Cedars-Sinai Medical Center

Summary:

The Food and Drug Administration’s recent approval of Prevnar, a new vaccine developed specifically for infants and toddlers, is expected to have a significant impact in the number of cases of pneumococcal infections – illnesses that can have devastating effects – according to Deborah Lehman, M.D., a specialist in pediatric infectious diseases at Cedars-Sinai Medical Center.

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LOS ANGELES (March 31, 2000) ---- The Food and Drug Administration’s recent approval of a new vaccine developed specifically for infants and toddlers is expected to have a significant impact in the number of cases of pneumococcal infections – illnesses that can have devastating effects – according to Deborah Lehman, M.D., a specialist in pediatric infectious diseases.

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Prevnar, the vaccine produced by American Home Products Corp., is intended to prevent pneumococcal bacteremia – infection of the bloodstream – and pneumococcal meningitis – infection of the lining of the brain and spinal cord.

“Pneumococcal meningitis is the worst-case scenario, with a fairly high mortality rate and a very high morbidity rate,” said Dr. Lehman, associate director of pediatric infectious diseases at Cedars-Sinai Medical Center. “This infection can cause hearing loss, developmental delay, mental retardation and many other long-term problems.”

Although Prevnar was developed to combat these life-threatening infections, it may also have several secondary benefits, according to Dr. Lehman. Some cases of pneumonia and many ear infections in young children are caused by pneumococcal bacteria. Therefore, parents and pediatricians may begin to see a decrease in these illnesses and over time, the number of antibiotic-resistant bacteria may decline.

“Because of the overuse of antibiotics, there are now strains of pneumococcal bacteria that are resistant to the first line of antibiotics we use. If the number of ear infections goes down, we may reduce the amount of antibiotics circulating through the community, making them more effective when they are needed,” said Dr. Lehman.

Jennifer Bleakley’s son came down with what appeared to be a routine childhood illness in January 1999, when Noah was only nine months old.

“He just seemed sick like they often get sick, like a cold or a flu. He had a fever and was under the weather, and I didn’t think too much of it, although he seemed fairly sick so I was keeping a close eye on it,” said Bleakley (pronounced Blakely). Her pediatrician kept a close watch, also, seeing Noah nearly every other day.

In addition to having a significant fever, Noah was extremely lethargic. At the doctor’s suggestion, Bleakley tried to reduce the fever, hoping Noah would become more energetic.

“One day when I was struggling with the fever and trying to get it down, and he was really pretty lethargic, I got him in the bath and got the fever down and he was just very pitiful and out of it,” Bleakley recalled. She took him to the pediatrician, who saw that Noah had developed a stiff neck, a common symptom of meningitis. The pediatrician instructed Bleakley to take Noah directly to the pediatric unit at Cedars-Sinai.

“When I got off the elevator, there was like a team of doctors waiting for us,” she said. “He was real sick. At a certain point, they had to basically bring in a whole team and revive him. It was awful.”

Noah’s infection responded quickly to antibiotics, he suffered no permanent injury, and he was released from the hospital after a 10-day stay. In fact, “by two or three days, he was running all over the hospital and making a lot of trouble,” Bleakley said. “It was pretty amazing.”

Bleakley’s pediatrician has suggested Noah be vaccinated against future pneumococcal infections as soon as Prevnar goes into wide circulation.

“I think it’s a very personal choice, whether to vaccinate or not. I have chosen to do it and I will probably give him this new vaccine,” Bleakley said. “For children who have, for whatever reason, some kind of susceptibility to this bacteria and this problem, obviously it’s a life-saver. I don’t think we would have been in that situation if the vaccine had been available. So that’s pretty compelling for me.”

During large-scale clinical trials, Prevnar produced only mild side effects such as irritability, decreased appetite, low-grade fevers, drowsiness and a slight reaction at the injection site. Dr. Lehman said that because these relatively minor complaints are consistent with vaccines that children currently receive for diphtheria, tetanus and pertussis – and the new vaccine will probably be given on the same schedule – parents will probably notice little or no difference in their children’s response.

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